BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK

    MDR report key: 4180242 · Received October 9, 2014

    Report

    Report Number
    4180242
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSING DOCUMENTATION AND INVESTIGATION REVEALS THAT A PTCA ABBOTT MINI TREK RX BALLOON (3.5 X15) WAS INSERTED INTO THE PROXIMAL LAD ARTERY SEGMENT-SAPHENOUS VEIN GRAPH AND BALLOON INFLATION TIMES THREE (6-8 ATM) FOR 5 SECONDS RESPECTIVELY. THE CATHETER WAS ABRUPTLY AND RAPIDLY REMOVED BY THE PHYSICIAN. A SEGMENT OF THE CATHETER/BALLOON WAS NOTED TO BE RETAINED WITHIN THE CATHETER SHEATH. AN ABBOTT NC TREK RX BALLOON 4.0 X 15 WAS USED TO SUCCESSFULLY RETRIEVE THE REMAINING SEGMENT. UPON INPECTION THE BALLOON WAS NOT IDENTIFIED. UPON REMOVAL OF THE SHEATH AND CAREFUL IRRIGATION A RUBBERY SUBSTANCE WAS IDENTIFIED AND EXAMINED. IT IS BELIEVED TO BE THE BALLOON. ALL DEVICES RETAINED.THE MANUFACTURER'S REP WAS PRESENT THROUGHT THE ENTIRE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636895 NC TREK WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR * 21119GA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR CATHETER SHEATH AND INTERVENTIONAL GUIDE WIRES.